The FDA continues its reorganization and as part of the transformation, the Office of Medical Policy has been rearranged into a so-called super office that will oversee regulation of prescription drug promotion and advertising; provide advice on clinical trial design; and direct policy issues concerning human subject protection and good clinical practices. The new director is Rachel Sherman and the deputy is Kathleen Uhl.
Meanwhile, the Division of Drug Marketing, Advertising, and Communications - which is known affectionately as Dee-Dee Mac - is being "elevated" into the Office of Prescription Drug Promotion. The new OPDP - rolls off the tongue like R2D2 - will be run by a familiar face - Tom Abrams, along with two associate directors - Mark Askine and Marci Kiester. Catherine Gray is the acting director for the Division of Professional Promotion, and Robert Dean is acting director, division of DTC promotion.
And the new Office of Medical Policy Initiatives, or OMPI, consists of an Immediate Office, the Division of Medical Policy Programs (DMPP), and the Division of Medical Policy Development (DMPD). The overall charter is to "develop and coordinate medical policy regulations and guidances that address the policy and program areas covered by the Super Office." Among its missions, support the Sentinel Initiative.
For those who enjoy the FDA's alphabet soup, the Patient Labeling Team (PLT) will be moving from the Office of Surveillance and Epidemiology (OSE), Division of Risk Management (DRISK) to OMPI, Division of Medical Policy Programs. The PLT is supposed to promote the safe and effective use of prescription meds. The OMPI director is Denise Hinton and the deputy director is Richardae Araojo.
12 Comments
I suppose the only appropriate observation would be "OMG?"
That might be 'Office of Management and Governance' - or not ...
The new Byzantium...
This is enough to give you PTSD.
I love it!. No longer will we have to say Dee-Dee-Mac. We can now say Opey-Dopey. Kinda rolls off the tongue.
One of my doctors would probably use one or two acronyms to describe this FDA reorganization, but I think Ed might get upset with me if I spell them out.
Just what the country has been asking for. More regulation.
Wonder when FDA will get around to updating its Web site? You'd think they would do that first.
At least Oregon already has a government institution called OPDP. So there's that.
Agree with Salient. The FDA web site has actually regressed in user friendliness. Used to be to look up info on a new or old drug you just had to click on "New Drug Approvals". Apparently the junior high school student web designer must have reported confusion between "new and "old" to the honchos at FDA, so that now you have to hyperlink to "Drugs at FDA" to get what you want. It's even harder to get history for approved BLA's. Salient, I fear that another revision might makes things worse, if that's possible. I can't wait until the web site incorporates these new acronyms.
Only two Western countries allow pharma to directly market their products to consumers(the U.S. and New Zealand). Perhaps DTC should be renamed Direct to Condition: The World Health Organization recently published their findings on the prevalence of "bipolar specturm disorder" in eleven countries. The United States led the list, while New Zealand was second. No amount of musical chairs will turn the FDA into the Superman it should be - to protect and adequately warn American consumers of prescription drugs, from which 100,000 die each year.
As for the FDA website, there's a reason for the obfuscation. Just imagine if the public actually learned what was going on.
Jon-If you feel like you can convince 5 US Supreme Court justices that banning pharma ads is not unconstitutional, you go right ahead.
Mind you, it may help to learn how to spell words like "spectrum."
This is more dizzying than opioids, and I think the point to be made would not be to convince 5 Supreme Court Justices of anything... but to convince the American People that their health and well-being is in their own hands and not in those of the government or the ever Increasing and Useless FDA. Maybe Mr. Salient would like to point out something of value other than that of ones mispelled word.
Nothing is easier than to ridicule FDA.
Meanwhile, all of us know (at least in our hearts, as Jimmy Carter used to say) that that's not where the problems really are.
The FDAs Whatever-The value brought by advertising is increased revenue (hopefully), as it should be in any capitalist country. That revenue gets sent to the shareholders.
A lot of those shareholders for the big drug companies are state & union pension funds for teachers, factory workers, firefighters, etc. Without this revenue, governments & industrial companies would have to find the money somewhere else, by raising taxes, reducing services, or both.
This concludes Econ 101 for today.